Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01066611
First received: January 27, 2010
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.


Condition Intervention Phase
Allergic Rhinitis
Drug: CAL-263
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Evaluate the safety of CAL-263 in allergic rhinitis subjects [ Time Frame: 46 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
CAL-263
Drug: CAL-263
CAL-263 10 mg or placebo once daily for 7 days
Placebo Comparator: 2
Placebo
Drug: Placebo
CAL-263 10 mg or placebo once daily for 7 days

Detailed Description:

A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 and <55 years
  2. Has a history of seasonal allergic rhinitis for at least 2 years
  3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
  4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
  5. Is otherwise healthy
  6. Is able to provide written informed consent

Exclusion Criteria:

  1. Is a female of childbearing
  2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
  3. History of nonallergic rhinitis, chronic sinusitis or severe asthma
  4. Has a nasal condition likely to affect the outcome of the study
  5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
  6. Has taken a prohibited medication within the specified interval prior to Visit 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066611

Locations
Austria
Vienna Challenge Chamber
Vienna, Austria
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber
  More Information

No publications provided

Responsible Party: Langdon Miller, M.D., VP Clinical Research, Oncology, Gilead Sciences
ClinicalTrials.gov Identifier: NCT01066611     History of Changes
Other Study ID Numbers: 263-02
Study First Received: January 27, 2010
Last Updated: May 4, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Gilead Sciences:
Allergic Rhinitis
Allergy
Phosphatidylinositol 3-kinase

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 22, 2014